Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2025-12-26 @ 4:31 PM
Study NCT ID:
NCT04395794
Status:
UNKNOWN
Last Update Posted:
2020-05-20
First Post:
2020-05-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SARS-CoV-2 Disguise Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000086742', 'term': 'COVID-19 Testing'}], 'ancestors': [{'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 900}, 'targetDuration': '8 Weeks', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-05-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2020-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-05-19', 'studyFirstSubmitDate': '2020-05-19', 'studyFirstSubmitQcDate': '2020-05-19', 'lastUpdatePostDateStruct': {'date': '2020-05-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'SARS-CoV-2 positive test', 'timeFrame': '8 weeks', 'description': 'Percentage of SARS-CoV-2 positive tests and increase of SARS-CoV-2 positive test between 1 st , 2 nd and 3 rd time frame testing'}], 'secondaryOutcomes': [{'measure': 'Transformation', 'timeFrame': '8 weeks', 'description': 'Percentage of transformation from asymptomatic SARS-CoV-2 positive carriers to symptomatic form'}, {'measure': 'Predictors (asymptomatic)', 'timeFrame': '8 weeks', 'description': 'Predictors of the asymptomatic SARS-CoV-2 positive carriers'}, {'measure': 'Predictors (symptomatic)', 'timeFrame': '8 weeks', 'description': 'Predictors of symptomatic form transformation'}, {'measure': 'Percentage from different departments', 'timeFrame': '8 weeks', 'description': 'Percentage of employees from different departments with SARS-CoV-2 positive carriers'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sars-CoV2']}, 'descriptionModule': {'briefSummary': 'Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection is a pandemic disease with worldwide spreading. Limited data are existed regarding SARS-CoV-2 positive carriers among asymptomatic medical employees in non-profile infectious clinic, e.g. cardiovascular clinic, routinely working in the pandemic region with two million inhabitants. The aim is to test the percentage and increase of the SARS-CoV-2 positive carriers among asymptomatic medical employees in high-volume cardiovascular center in routine clinical practice.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Asymptomatic medical employees in high-volume cardiovascular center', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Asymptomatic medical employees of E. Meshalkin National Medical Research Center of the Ministry of Health of the Russian Federation\n* Filled questionnaire before SARS-CoV-2 testing\n* Nasopharyngeal and oropharyngeal testing for SARS-CoV-2\n* Signed informed consent\n\nExclusion Criteria:\n\n* Unwilling to participate'}, 'identificationModule': {'nctId': 'NCT04395794', 'acronym': 'Disguise', 'briefTitle': 'SARS-CoV-2 Disguise Study', 'organization': {'class': 'NETWORK', 'fullName': 'Meshalkin Research Institute of Pathology of Circulation'}, 'officialTitle': 'SARS-CoV-2 Positive Carriers Among Asymptomatic meDIcal employeeS in hiGh-volUme cardIovaScular cEnter', 'orgStudyIdInfo': {'id': 'CS-COVID-19'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Medical Employees', 'description': 'Asymptomatic medical employees in high-volume cardiovascular center.', 'interventionNames': ['Diagnostic Test: SARS-CoV-2-test', 'Other: SARS-CoV-2 questionnaire survey']}], 'interventions': [{'name': 'SARS-CoV-2-test', 'type': 'DIAGNOSTIC_TEST', 'description': 'Nasopharyngeal and oropharyngeal testing for SARS-CoV-2', 'armGroupLabels': ['Medical Employees']}, {'name': 'SARS-CoV-2 questionnaire survey', 'type': 'OTHER', 'description': 'Questionnaire regarding SARS-CoV-2 symptoms and contact with COVID patients', 'armGroupLabels': ['Medical Employees']}]}, 'contactsLocationsModule': {'locations': [{'zip': '630055', 'city': 'Novosibirsk', 'status': 'RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Alexander B Romanov, PhD', 'role': 'CONTACT', 'email': 'abromanov@mail.ru', 'phone': '+79137172652'}, {'name': 'Vladimir V Lomivorotov, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Dmitry N Ponomarev, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Denis V Losik, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Igor L Mikheenko', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Vladimir V Beloborodov', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Nurlan A Elemesov', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Meshalkin National Medical Research Center', 'geoPoint': {'lat': 55.02259, 'lon': 82.93175}}], 'centralContacts': [{'name': 'Alexander B Romanov, PhD', 'role': 'CONTACT', 'email': 'abromanov@mail.ru', 'phone': '+79137172652'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Meshalkin Research Institute of Pathology of Circulation', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}